M. D. Anderson Cancer Center To Lead Study Of Surgery Vs. CyberKnife(R) Radiosurgery For Operable Lung Cancer Patients

Main Category: Lung Cancer
Also Included In: Radiology / Nuclear Medicine;  Clinical Trials / Drug Trials
Article Date: 27 Oct 2007 - 0:00 PDT

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Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced that the company is partnering with The University of Texas M. D. Anderson Cancer Center in Houston, Texas to launch a prospective clinical study to compare treatment outcomes in early-stage operable lung cancer. Patients in the study will be randomly assigned to traditional surgery or CyberKnife(R) Robotic Radiosurgery for their treatment.

In the past several years evidence has grown showing excellent outcomes in the treatment of lung tumors with high-dose radiation delivered in three or four treatments. Study results on operable patients treated by these short courses have demonstrated survival rates and local control rates similar to those of traditional surgery. As the medical community moves toward adoption of more minimally invasive alternatives to treatment, data that compare outcomes of surgery to less invasive treatment options, such as radiosurgery, become extremely important.

"We feel the time is right to explore less invasive alternatives for early stage lung cancer patients," said Jack Roth, M.D., professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic & Cardiovascular Surgery at M. D. Anderson and the study's principal investigator. "The results achieved with radiosurgery appear to be comparable to those achieved with traditional surgery for early stage lung cancer patients and a randomized clinical trial is required to accurately compare results from the two. To do so, we must use a uniform platform to assure the highest possibility of cure for these patients, which is why we are partnering with Accuray to use the CyberKnife System. The results of this study may change the way lung cancer patients are treated."

Additionally, Ritsuko Komaki, M.D., professor of Radiation Oncology and program director, Thoracic Radiation Oncology and Joe Y. Chang, M.D., Ph.D., assistant professor of Radiation Oncology and Clinical Service Chief, Thoracic Radiation Oncology, are co-principal investigators on the study.

Sites from around the world will participate in this 1,200-patient study, with coordination and oversight by the M. D. Anderson team. The goal of the study is to compare treatment outcomes between surgery and CyberKnife radiosurgery across a broad range of geographic healthcare markets. Patient accrual is expected to begin in early 2008.

A major factor in the success of this study is selecting the most accurate method of treatment that will maximize radiation to the tumor and minimize damage to surrounding healthy tissue. Accuray's CyberKnife System combined with the company's Synchrony(R) Respiratory Tracking System and Xsight(R) Lung Tumor Tracking System allow patients to receive a completely non-invasive treatment in three to four days through the precise delivery of high-dose radiation. While the patient lies comfortably and breathes normally, the CyberKnife System continually tracks the tumor to maximize targeting accuracy and minimize damage to surrounding healthy tissue. Treatments are performed in an outpatient setting, without the expected complications of an invasive surgical procedure.

"Over the past five years clinicians have obtained excellent outcomes treating lung cancer with CyberKnife Radiosurgery," said Omar Dawood, M.D., MPH, vice president of Clinical Development of Accuray Incorporated. "We believe the CyberKnife System's unique ability to track tumor motion and deliver radiation accurately and non-invasively make it the ideal platform for this clinical study. We are excited about this partnership with M. D. Anderson, a leader in cancer treatment, and the huge benefits this study's outcomes could have for patients with lung cancer."

M. D. Anderson is currently ranked number one nationwide in cancer care, according to the U.S. News & World Report's 2007 America's Best Hospitals report.

About the CyberKnife(R) Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non- invasively and with sub-millimeter accuracy. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver precise, high-dose radiation, minimizing damage to surrounding healthy tissue and eliminating the need for invasive head or body stabilization frames.

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a non-surgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 35,000 patients worldwide and currently more than 100 systems have been installed in leading hospitals in the Americas, Europe and Asia. For more information, please visit http://www.accuray.com.

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The foregoing may contain certain forward-looking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release regarding procedure growth and market acceptance, clinical studies, regulatory review and approval, and commercialization of products are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward- looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: market acceptance of products; competing products; need for additional long-term clinical data; the combination of our products with complementary technology; and other risks detailed from time to time under the heading "Risk Factors" in our report on Form 10-K for the fiscal year ended June 30, 2007 and may be updated from time to time by our other filings with the Securities and Exchange Commission. The Company's actual results of operations may differ significantly from those contemplated by such forward- looking statements as a result of these and other factors. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.

Accuray Incorporated
http://www.accuray.com

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